Open AccessQuality assurance in clinical laboratories—from the auditor's viewpoint
Author(s) -
Kuramochi Masahiro
Publication year - 1998
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/(sici)1099-1786(199806)3:2<61::aid-qaj62>3.0.co;2-y
Subject(s) - good laboratory practice , quality assurance , audit , good clinical practice , quality (philosophy) , quality audit , medical physics , clinical audit , medicine , clinical trial , quality management system , work (physics) , good manufacturing practice , business , operations management , quality management , engineering , accounting , external quality assessment , pathology , regulatory affairs , mechanical engineering , management system , philosophy , epistemology
In Japan, issues discussing quality assurance (QA) of clinical laboratories come from the historical fact that QA has been determined only through interpretation of the text of Good Clinical Practice (GCP). According to the provisions of Japanese GCP, a medical institution conducting clinical studies refers to a hospital and not to a clinical laboratory. In contrast to Good Laboratory Practice (GLP), which is applied to non‐clinical laboratories, GCP has few descriptions on laboratory work, such as tests and analytical work, and hence, requirements for institutions specialized in clinical laboratory tests remain unclear. Essentially, both GLP and GCP are the standards for conducting clinical studies, which are needed for the examination of new drug approvals, and both have a common purpose which is to improve the quality of studies and ensure that quality issues are taken into account. Further, the newly added article ‘Standards for Quality of Application Documents’ is applied to all documents to be submitted for new drug approvals, whether the documents come from preclinical or clinical studies, and covers both areas with a single standard provision. That means both GCP and GLP have a common principle. For a clinical laboratory to perform tests in compliance with GCP, it should first comply completely with provisions similar to those stipulated in GLP, except for provisions concerning human subjects. The FDA's audit manual for clinical laboratories (analytical facilities) has almost the same content and requirements as that of GLP. Copyright © 1998 John Wiley & Sons, Ltd.